Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder
- Conditions
- Insomnia Disorder
- Interventions
- Registration Number
- NCT03545191
- Lead Sponsor
- Idorsia Pharmaceuticals Ltd.
- Brief Summary
The main purpose of this study is to assess efficacy and safety of ACT-541468 (daridorexant) in adult and elderly subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 930
- Signed informed consent prior to any study-mandated procedure;
- Male or female aged ≥ 18 years;
- Insomnia disorder according to DSM-5 criteria;
- Insomnia Severity Index score ≥ 15;
- Insufficient sleep quantity as collected subjectively in the sleep diary;
- Women of childbearing potential must have a negative and urine pregnancy test and use the contraception scheme up to at least 30 days after last study treatment intake.
- Body mass index below 18.5 or above 40.0 kg/m2;
- Any lifetime history of of related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement (REM) behavior disorder, narcolepsy, or apnea/ hypopnea;
- Cognitive behavioral therapy (CBT) only allowed if, the treatment started at least 1 month prior to Visit 3 and the subject agrees to continue this CBT throughout the study;
- Self-reported usual daytime napping ≥ 1 hour per day and ≥ 3 days per week;
- Acute or unstable psychiatric conditions diagnosed by the Mini International Neuropsychiatric Interview;
- Mini Mental State Examination (MMSE) score < 25 in subjects ≥ 50 years;
- For female subjects: pregnant, lactating or planning to become pregnant during projected duration of the study;
- History or clinical evidence of any disease or medical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the study assessments.
- Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Daridorexant 50 mg Daridorexant 50 mg - Placebo Placebo - Daridorexant 25 mg Daridorexant 25 mg -
- Primary Outcome Measures
Name Time Method Change From Baseline to Month 1 in Wake After Sleep Onset (WASO) (Sleep Maintenance) From baseline to Month 1 (i.e. for up to 1 month) "Wake After Sleep Onset" is the time spent awake after onset of persistent sleep until lights on, as determined by polysomnography.
Change From Baseline to Month 3 in Wake After Sleep Onset (WASO) From baseline to Month 3 (i.e. for up to 3 months) "Wake After Sleep Onset" is the time spent awake after onset of persistent sleep until lights on, as determined by polysomnography.
Change From Baseline to Month 3 in Latency to Persistent Sleep (LPS) From baseline to Month 3 (i.e. for up to 3 months) "Latency to Persistent Sleep" is the time from start of recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-awake, i.e., epochs scored as either sleep stage 1 (S1), sleep stage 2 (S2), sleep stage 3 (slow wave sleep) or REM, as determined by polysomnography.
Change From Baseline to Month 1 in Latency to Persistent Sleep (LPS) (Sleep Onset) From baseline to Month 1 (i.e. for up to 1 month) "Latency to Persistent Sleep" is the time from start of recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-awake, i.e., epochs scored as either sleep stage 1 (S1), sleep stage 2 (S2), sleep stage 3 (slow wave sleep) or REM, as determined by polysomnography.
- Secondary Outcome Measures
Name Time Method Change From Baseline to Month 3 in the Subjective Total Sleep Time (sTST) From baseline to Month 3 (i.e. for up to 3 months) "Subjective Total Sleep Time" is the total sleep time reported by the participant in the sleep diary questionnaire. A positive change from baseline indicates an increase in the subjective Total Sleep Time. A negative change from baseline indicates a decrease in subjective Total Sleep Time.
Change From Baseline to Month 1 in Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) Sleepiness Domain Score From baseline to Month 1 (i.e. for up to 1 month) The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is a validated patient reported outcome instrument comprising 14 items (each using a numeric rating scale from 0 to 10) grouped into three domains (i.e., sleepiness, mood, and alert/cognition) reflecting daytime impairment of insomnia. The IDSIQ sleepiness domain has 4 items, and the domain score ranges from 0 to a maximum of 40, where a higher score indicates a greater burden. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Change From Baseline to Month 3 in IDSIQ Sleepiness Domain Score From baseline to Month 3 (i.e. for up to 3 months) The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is a validated patient reported outcome instrument comprising 14 items (each using a numeric rating scale from 0 to 10) grouped into three domains (i.e., sleepiness, mood, and alert/cognition) reflecting daytime impairment of insomnia. The IDSIQ sleepiness domain has 4 items, and the domain score ranges from 0 to a maximum of 40, where a higher score indicates a greater burden. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Change From Baseline to Month 1 in the Subjective Total Sleep Time (sTST) From baseline to Month 1 (i.e. for up to 1 month) "Subjective Total Sleep Time" is the total sleep time reported by the participant in the sleep diary questionnaire. A positive change from baseline indicates an increase in the subjective Total Sleep Time. A negative change from baseline indicates a decrease in subjective Total Sleep Time.
Trial Locations
- Locations (81)
PAB Clinical Research
🇺🇸Brandon, Florida, United States
Klinische Forschung Hamburg GmbH
🇩🇪Hamburg, Germany
emovis GmbH
🇩🇪Berlin, Germany
Jodha Tishon Inc.
🇨🇦Toronto, Canada
Ospedale San Raffaele - Centro per i Disturbi del Sonno San Raffaele - Ville-Turro - Pallazzina E
🇮🇹Milano, Italy
Hospital de La Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
Synexus Leipzig Research Centre
🇩🇪Leipzig, Germany
Tri-Hospital Sleep Laboratory West
🇨🇦Mississauga, Canada
Hospital General de Castellon
🇪🇸Castelló de la Plana, Spain
Klinische Forschung Karlsruhe GmbH
🇩🇪Karlsruhe, Germany
Gold Coast University Hospital, Respiratory Medicine and Sleep Services
🇦🇺Southport, Australia
Westmead Hospital, Department of Respiratory and Sleep Medicine
🇦🇺Westmead, Australia
St Hedwig-Krankenhaus, Klinik für Schlaf- und Chronomedizin
🇩🇪Berlin, Germany
AOU Citta della Salute e della Scienza - Molinette - SSD Medicina del Sonno
🇮🇹Torino, Italy
CRIUSMQ- CIUSSSCN, CETS (clinique du sommeil)
🇨🇦Quebec, Canada
Klinikum Rechts der lsar TU München Dept. of Psychiatry and Psychotherapy
🇩🇪München, Germany
Instituto de Investigaciones del Sueno
🇪🇸Madrid, Spain
Centro Médico Teknon - Medicina del Sueño
🇪🇸Barcelona, Spain
Hospital Universitari Vall d'Hebron - Neurophisiology Deparment - Sleep Unit
🇪🇸Barcelona, Spain
Studienzentrum Wilhelmshöhe GmbH
🇩🇪Kassel, Germany
KSM Bad Zurzach, Klinik für Schlafmedizin
🇨🇭Bad Zurzach, Switzerland
San Carlos University Hospital - Servicio de Neurofisiología Clínica
🇪🇸Madrid, Spain
Pinnacle Research Group, LLC
🇺🇸Anniston, Alabama, United States
Preferred Research Partners, Inc
🇺🇸Little Rock, Arkansas, United States
Marvel Clinical Research
🇺🇸Huntington Beach, California, United States
Long Beach Clinical Trials
🇺🇸Long Beach, California, United States
Canvas Clinical Research, LLC
🇺🇸Lake Worth, Florida, United States
LaPorte County Institute for Clinical Research
🇺🇸Michigan City, Indiana, United States
Helene Emsellem, MD
🇺🇸Chevy Chase, Maryland, United States
Infinity Medical Research, Inc.
🇺🇸North Dartmouth, Massachusetts, United States
Barrett Clinic
🇺🇸La Vista, Nebraska, United States
Clinilabs NYC
🇺🇸New York, New York, United States
Oregon Center for Clinical Investigations,Inc
🇺🇸Salem, Oregon, United States
Research Carolina of Huntersville
🇺🇸Huntersville, North Carolina, United States
Coastal Carolina Healthcare
🇺🇸New Bern, North Carolina, United States
BTC of Lincoln
🇺🇸Lincoln, Rhode Island, United States
Omega Medical Research
🇺🇸Warwick, Rhode Island, United States
Coastal Carolina Research Center
🇺🇸Mount Pleasant, South Carolina, United States
Inquest Clinical Research
🇺🇸Baytown, Texas, United States
Aspen Clinical Research
🇺🇸Orem, Utah, United States
Sleep Disorders Centers of the Mid-Atlantic
🇺🇸Vienna, Virginia, United States
Respiratory Clinical Trials
🇦🇺Adelaide, Australia
Genesis Sleep Care Queensland
🇦🇺Auchenflower, Australia
Melbourne Sleep Disorders Centre
🇦🇺East Melbourne, Australia
Royal Melbourne Hospital, Department of Respiratory Medicine
🇦🇺Parkville, Australia
The Woolcock Institute of Medical Research
🇦🇺Glebe, Australia
Scan Sleep Specialists
🇩🇰København, Denmark
Universitätsklinik für Neurologie, Inselspital Bern, Schlaf-Wach-Epilepsie-Zentrum
🇨🇭Bern, Switzerland
Tri-State Mountain Neurology
🇺🇸Johnson City, Tennessee, United States
General Hospital Bel Medic, Center for Sleep disorders
🇷🇸Belgrade, Serbia
Medigroup - Health Center Dr Ristic (MediGroup Dom zdravlja "Dr Ristic") - Neurology Department
🇷🇸Novi Beograd, Serbia
Woodland Research Northwest
🇺🇸Rogers, Arkansas, United States
PI-House - Centrum Badań Klinicznych
🇵🇱Gdańsk, Poland
Ośrodek Medycyny Study Nurseu Instytutu Psychiatrii i Neurologii (Sleep Disorders Center)
🇵🇱Warsaw, Poland
Universitäre Psychiatrische Kliniken Basel (Upk)
🇨🇭Basel, Switzerland
EMC Instytut Medyczny SA, Przychodnia przy Łowieckiej
🇵🇱Wroclaw, Poland
Zentrum für Schlafmedizin Zürcher Oberland, Zürcher RehaZentrum Wald
🇨🇭Wald, Switzerland
Zentrum für Schlafmedizin GZO AG Spital Wetzikon
🇨🇭Wetzikon, Switzerland
IRCCS FONDAZIONE Istituto Neurologico Nazionale "Casimiro Mondino" - Centro di Ricerca Interdipartimentale per la SSclerosi Multipla (CRISM) -
🇮🇹Pavia, Italy
Azienda Ospedaliero Universitaria Pisana - Ospedale S. Chiara - Centro di Medicina del Sonno - Clinica Neuroligica - Dipartimento de Neuroscienze
🇮🇹Pisa, Italy
MedSleep
🇨🇦Toronto, Canada
Hospital MAZ - Neurophisiology and Sleep Department
🇪🇸Zaragoza, Spain
Hospital Universitario Araba - Unidad Funcional de Trastornos del Sueño
🇪🇸Vitoria-Gasteiz, Spain
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
BioMed Research Institute
🇺🇸Miami, Florida, United States
Pulmonary Associates of the Southeast/WCR
🇺🇸Birmingham, Alabama, United States
St. Francis Sleep Allergy and Lung Institute
🇺🇸Clearwater, Florida, United States
Innovative Clinical Research, Inc.
🇺🇸Hialeah, Florida, United States
Research Centers of America
🇺🇸Hollywood, Florida, United States
Clinical Site Partners, LLC
🇺🇸Winter Park, Florida, United States
Clinical Research Center of Nevada
🇺🇸Las Vegas, Nevada, United States
CTI Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
Bogan Sleep Consulting, LLC
🇺🇸Columbia, South Carolina, United States
Sleep Therapy & Research Center
🇺🇸San Antonio, Texas, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Synexus Berlin Research Centre
🇩🇪Berlin, Germany
Clinical Trial Center North GmbH & Co. KG
🇩🇪Hamburg, Germany
Kinische Forschung Schwerin GmbH
🇩🇪Schwerin, Germany
ZMS Zentrum für medizinische Studien GmbH
🇩🇪Warendorf, Germany
Kentucky Research Group
🇺🇸Louisville, Kentucky, United States
Pulmonary Associates of Richmond
🇺🇸Richmond, Virginia, United States